Pharmacokinetics of Butyrate Tablet BKR-017
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT06556745
- Lead Sponsor
- BioKier Inc.
- Brief Summary
The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.
- Detailed Description
BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (\>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing (Figure 4). On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed by Southern Research using the butyric acid ELISA kit provided by Biomatik (#EKU08762). All regulations will be met according to FDA regulations governing human subject protection and the conduct of clinical trials.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Men and women, ages 18-70 inclusive
- Subjects currently on statin treatments.
- Presence of cirrhosis, or other causes of liver disease
- Substantial alcohol consumption (>20 g/day for women or >30 g/day for men)
- History of bariatric or intestinal surgery
- Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis.
- Active and clinically significant pancreatic disease, or renal disease as determined by the investigator.
- History of heart disease that in the opinion of the investigator should exclude the subject from the study.
- Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- Active significant infection as determined by the investigator.
- Known allergy to butyrate or any of the components of the tablets.
- Participation in a clinical trial and/or Dosing with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
- Pregnant, nursing, or trying to become pregnant.
- In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
- Subject is taking one or more of the excluded therapies or ≥4 drugs in total.
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of butyrate 8 days Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing.
Area under the plasma concentration versus time curve (AUC) 8 days AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure 8 days An assessment of safety will be made using blood pressure at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel 8 days Hematology (CBC) will be performed at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by heart rate 8 days An assessment of safety will be made using heart rate at screening, after single dose, and after 7 days repeat dosing.
Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters 8 days An assessment of chemistry laboratory safety parameters will be performed at screening, after single dose, and after 7 days repeat dosing.